ORTHOPAEDIC CABLE SYSTEM— 510(k) K842977

Substantially Equivalent

Richards Medical Co., Inc.

FDA 510(k) clearance K842977 for ORTHOPAEDIC CABLE SYSTEM, Substantially Equivalent on 1984-10-26. Applicant: Richards Medical Co., Inc.. Device class: 2.

Clearance details

Applicant
Richards Medical Co., Inc.
Product code
Code JDQ
Device class
Class 2
Regulation
21 CFR 888.3010
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Memphis, TN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JDQ

product code JDQ
Death
9
Injury
330
Total
339

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.